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CancerPRISM-ACNCT03668223

The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

A study testing Promoting Resilience in Stress Management (PRISM) in people with Cancer and Quality of Life, run by Dana-Farber Cancer Institute at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults with Advanced Cancer Read more about this study

Who is it for?
Ages 12 to 24 years
Conditions the study is for
Cancer, Quality of Life, Anxiety
What is being tested?
Promoting Resilience in Stress Management (PRISM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
5 sitesUnited States
Study dates
15 Apr 2019to 31 Oct 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 12-24 years
  • Diagnosed with advanced cancer: progressive, recurrent, refractory disease or any diagnosis with estimated overall survival <50% at least 2 weeks prior to enrollment
  • Able to speak English
  • Able to read English or Spanish
  • Cognitively able to participate in interviews

Who cannot join

  • Patient Refusal
  • Parent Refusal (if patient <18 years-old)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Children's Hospital Los Angeles

    Los Angeles, California, 900278

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Seattle Children's Hospital

    Seattle, Washington, 98145

Other trials in United States

About this study

Official title: The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults with Advanced Cancer

Read the detailed description

Among patients with cancer and their families, early integration of palliative care may improve quality of life. This is particularly important for Adolescents and Young Adults (AYAs) because their distinct developmental challenges related to identity, relationships, and vocation may add to the burden of cancer. Among AYAs with advanced cancer, most understand that they may die and report that discussing end-of-life preferences, goals, and fears would be helpful; however, only 53% engage in such conversations. While national guidelines call for integrated palliative care in AYA oncology, developmentally targeted, evidence-based interventions designed to meet psychosocial and communication needs are lacking.

A potential barrier to improving the experiences of AYAs with advanced cancer may be their limited opportunities to develop "resilience resources" such as stress-management, goal-setting, positive reframing, and meaning-making skills. These resources may mitigate negative outcomes, facilitate engagement in goals of care discussions, and improve quality of life. Furthermore, promoting these resources among AYAs may give them the tools to more successfully navigate the challenges of the cancer experience.

Our research program is built on the central hypothesis that promoting resilience resources will improve psychosocial well-being. Over a series of studies, we developed a conceptual framework of resilience in pediatric cancer, affirmed associations between resilience resources and outcomes, and developed a novel resilience resources intervention (Promoting Resilience in Stress Management, PRISM). PRISM is a manualized, skills-based training program comprised of four 30-60 minute, in-person, one-on-one sessions plus a facilitated parent/caregiver/spouse/significant other family-meeting.

We completed a pilot Randomized Controlled Trial (RCT) to test the efficacy of PRISM among 100 AYAs, 6-months following their diagnosis of new (n=73) or recurrent (n=27) cancer. Results suggest PRISM is feasible, highly acceptable, and associated with increased patient-reported resilience as well as key clinically significant patient-centered outcomes such as quality of life and psychological distress. Subgroup analyses comparing patients with advanced cancer to those with new cancer suggested differentially stronger positive effects in the advanced cancer group, raising a hypothesis to be tested in dedicated trials. However, qualitative feedback from patients with advanced cancer suggested refinements targeting hopes, worries, and contextual meaning-making might strengthen PRISM's usefulness.

The overall objective of this project is to refine PRISM to meet the distinct needs of AYAs with Advanced Cancer. We will first adapt and iteratively test the existing PRISM based on established guidelines for intervention development. Then, we will conduct a multi-site randomized controlled trial to test the efficacy of a new PRISM for Advanced Cancer (PRISM-AC). Findings will inform the development of larger dissemination studies and standards of AYA end-of-life and palliative care. Ultimately, this research has the potential to reduce the burden of cancer in a highly vulnerable population.

Being tested
Promoting Resilience in Stress Management (PRISM)
Medical subject headings
Neoplasms, Anxiety Disorders, Depression, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Promoting Resilience in Stress Management (PRISM)Behavioural

    Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Study groups in NCT03668223
Study groupRoleWhat they receive
Promoting Resilience in Stress Management (PRISM)ExperimentalResilience Skills Training
Receives: Behavioral: Promoting Resilience in Stress Management (PRISM)
Usual CareNo interventionStandard psychosocial care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pediatric Quality of Life Cancer Module

    Pediatric Quality of Life (PedsQL) Cancer Module -This scale was designed to assess pediatric cancer-specific health related quality of life. This is a 27 item scale, with each item rated on a 5-point Likert scale where 0=never and 4=almost always. Higher scores represent better health-related quality of life. Scale range is 0-100.

    Measured: 3-months

Secondary outcomes (3)

  1. Hospital Anxiety and Depression Scale (HADS) Total Score

    The Hospital Anxiety and Depression Scale total score is a 14 items scale on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression. The total score is the sum of all 14 items, ranging from 0-42. Higher scores indicate higher total anxiety/depression.

    Measured: 3-months

  2. Snyder Hope Scale

    Hope: The Snyder "Hope" Scale measures "the overall perception that one's goals can be met." The instrument scored on an 8-point Likert scale (score range 0-64). Higher scores imply greater levels of hopeful thought patterns.

    Measured: 3-months

  3. Connor Davidson Resilience Scale

    Resilience: The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. This is a 10-item scale ranging from 0-40 where higher scores reflect greater perceived resilience.

    Measured: 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start15 Apr 2019
  3. Primary completion23 Jan 2024
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03668223
Sponsor's protocol ID
22-653
Other IDs
STUDY00001229, R01CA222486
Acronym
PRISM-AC
Status last verified
Sep 2026
First submitted
15 Aug 2018
Last updated
14 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • Rosenbaum ARP, Ream M, Fladeboe KM, Lau N, Yi-Frazier JP, Rosenberg AR. Examining Sociodemographic Differences in Response to Resilience Coaching for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation-A Post Hoc Analysis of the PRISM Intervention. Pediatr Blood Cancer. 2025 Nov;72(11):e31998. doi: 10.1002/pbc.31998. Epub 2025 Aug 31.

    PubMed 40887863

  • Rosenberg AR, Fladeboe KM, Zhou C, Bradford MC, Kang T, Maurer S, Freyer DR, Baker KS, Comiskey L, Junkins CC, Taylor MR, Yi-Frazier JP. Promoting Resilience in Stress Management: A Randomized Controlled Trial of a Novel Psychosocial Intervention for Adolescents and Young Adults With Advanced Cancer. JCO Oncol Pract. 2026 Feb;22(2):243-254. doi: 10.1200/OP-25-00161. Epub 2025 Apr 28.

    PubMed 40294356

  • O'Daffer A, Comiskey L, Scott SR, Zhou C, Bradford MC, Yi-Frazier JP, Rosenberg AR. Protocol for the promoting resilience in stress management (PRISM) intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. BMC Palliat Care. 2023 May 16;22(1):60. doi: 10.1186/s12904-023-01179-4.

    PubMed 37189149

  • O'Daffer A, Comiskey L, Scott SR, Zhou C, Bradford MC, Yi-Frazier JP, Rosenberg AR. Protocol for The Promoting Resilience in Stress Management (PRISM) Intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. Res Sq [Preprint]. 2023 Apr 7:rs.3.rs-2748874. doi: 10.21203/rs.3.rs-2748874/v1.

    PubMed 37066150

Questions about this trial

What is this clinical trial studying?

A study testing Promoting Resilience in Stress Management (PRISM) in people with Cancer and Quality of Life, run by Dana-Farber Cancer Institute at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pediatric Quality of Life Cancer Module (time frame: 3-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03668223, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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